Early Intestinal Ultrasound in Predicting Treatment Response to Filgotinib in Ulcerative Colitis

Ulcerative Colitis Clinical Trial

— STEER  

Official title:

Intestinal Ultrasonography in Ulcerative Colitis Patients Treated With Filgotinib

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05653791
• Other study ID #: W22_205 # 22.254
• Status: Active, not recruiting
• Start date: October 1, 2022
• Est. completion date: October 1, 2024

Study information

• Verified date: December 2022
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Objective disease assessment in inflammatory bowel diseases at the time of treatment initiation and during follow-up has become gold standard. However, biomarkers, such as C-reactive protein and fecal calprotectin, fail to provide information on disease extent, location or complications. Repeated endoscopic assessments are performed to evaluate mucosal response to treatment, though associated costs, availability, invasiveness and patient preference are considerable limitations. Recently, intestinal ultrasound (IUS) has gained significant momentum as a non-invasive, easily accessible and low-cost alternative for objective assessment. Accordingly, the ECCO-ESGAR guideline recognizes IUS as a potential tool for the diagnosis and for the monitoring of IBD.

Our study aim is to evaluate the change in intestinal ultrasound parameters (as measured by B-mode and SWE at baseline and week 4) to predict endoscopic response and remission as defined by the follow-up endoscopy and measured by the Mayo endoscopic subscore and the UCEIS during treatment with filgotinib

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: October 1, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• =18 years of age

• Endoscopic and/or histological confirmed diagnosis of UC

• UC disease extent proximal to the rectum (ie, left-sided colitis or pancolitis)

• Moderately to severely active UC, defined by an endoscopic Mayo score of = 2

• Indication for receiving filgotinib treatment

Exclusion Criteria:

• Pregnancy

• Inability to give informed consent

• Proctitis only

• Ongoing gastroenteritis

• (Sub)total colectomy

• Obesity (BMI >35 kg/m²)

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Diagnostic Test:
• Intestinal ultrasound
Ulcerative colitis patients treated with filgotinib will undergo intestinal transabdominal ultrasound at baseline, week 4 and at the time of the follow-up endoscopy (week 10-16)

Locations

Country	Name	City	State
Netherlands	Amsterdam UMC	Amsterdam-Zuidoost	Noord-holland

Sponsors (2)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)	Galapagos NV

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	• Can early (baseline to week 4) changes in IUS parameters (B-mode and SWE) predict long-term clinical (defined by a decrease of = 3 in SCCAI) response at 1 year		between baseline and 52 weeks / 1 year
Other	• Can early (baseline to week 4) changes in IUS parameters (B-mode and SWE) predict long-term clinical (defined by SCCAI = 2) remission at 1 year		between baseline and 52 weeks / 1 year
Other	• Can early (baseline to week 4) changes in IUS parameters predict long-term biochemical response at 1 year (measured by fecal calprotectin <250 µg/g )		between baseline and 52 weeks / 1 year
Other	• to explore whether early (baseline to week 4) changes in IUS parameters can predict long-term biochemical remission at 1 year (measured by fecal calprotectin <150 µg/g )		between baseline and 52 weeks / 1 year
Primary	Evaluate the change in intestinal ultrasound parameters to predict endoscopic response as defined by the follow-up endoscopy measured by the Mayo endoscopic subscore during treatment with filgotinib		10-16 weeks
Primary	Evaluate the change in intestinal ultrasound parameters to predict endoscopic response as defined by the follow-up endoscopy and measured by the Ulcerative Colitis Endoscopic Index of Severity (UCEIS) during treatment with filgotinib		10-16 weeks
Primary	Evaluate the change in intestinal ultrasound parameters to predict endoscopic remission as defined by the follow-up endoscopy and measured by the Mayo endoscopic subscore during treatment with filgotinib		10-16 weeks
Primary	Evaluate the change in intestinal ultrasound parameters to predict endoscopic remission as defined by the follow-up endoscopy and measured by the Ulcerative Colitis Endoscopic Index of Severity (UCEIS) during treatment with filgotinib		10-16 weeks
Secondary	evaluate the change in IUS parameters (B-mode and shear-wave elastography (SWE; in kPa) at baseline and week 4) to predict clinical response during follow-up endoscopy	B-mode: bowel wall thickness (BWT), colour doppler signal (CDS), loss of stratification, loss of haustration and presence of lymph nodes	10-16 weeks
Secondary	evaluate the change in IUS parameters (B-mode and SWE; measured in kPa) at baseline and week 4) to predict clinical remission during follow-up endoscopy		10-16 weeks
Secondary	• to evaluate the change in IUS parameters (as measured by B-mode and SWE at baseline and week 4) to predict biochemical response and remission at the time of the follow-up endoscopy.		10-16 weeks
Secondary	• to evaluate the change in IUS parameters (as measured by B-mode and SWE at baseline and week 4) to predict histological remission at the time of the follow-up endoscopy		10-16 weeks
Secondary	• to evaluate IUS parameters (as measured in B-mode) in predicting biochemical remission at 1 year (as defined by fecal calprotectin< 150 ug/g)		52 weeks / 1 year
Secondary	• to evaluate IUS parameters (as measured in B-mode) in predicting cortico-steroid-free remission at 1 year		52 weeks / 1 year
Secondary	• to evaluate IUS parameters (as measured in B-mode) in predicting clinical remission at 1 year (as defined by the Simple Clinical Colitis Activity Index (SCCAI) = 2)		52 weeks / 1 year
Secondary	• to evaluate if addition of calprotectin to early IUS (at week 4) could better predict endoscopic response as defined by the follow-up endscopy than IUS or calprotectin alone.		4 weeks
Secondary	• to evaluate if addition of calprotectin to early IUS (at week 4) could better predict endoscopic remission as defined by the follow-up endscopy than IUS or calprotectin alone.		4 weeks
Secondary	• to evaluate individual wall layer thickness, with special regard to the submucosa, in relation to response to treatment		10-16 weeks
Secondary	• to describe SWE (measured in kPa) in patients with moderate to severe UC		10-16 weeks
Secondary	• correlate SWE (measured in kPa) with endoscopic findings of disease severity (measured by the Mayo endoscopic subscore)		10-16 weeks
Secondary	• correlate SWE (measured in kPa) with endoscopic findings of disease severity (measured by the UCEIS subscore)		10-16 weeks
Secondary	• to evaluate correlation between SWE findings and characteristics of the submucosa, including wall layer thickness and hyperechogenicity		10-16 weeks
Secondary	• to evaluate the correlation between segmental healing upon endoscopy and IUS		10-16 weeks